MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630001

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 10/24/2021

Event Type  Injury  

Event Description

Arjo became aware that a patient has developed combined masd (moisture-associated skin damage) and "unstageable" pressure ulcer to the right buttock at time of use an arjo auto logic system.The patient¿s family raised concerns with the mattress which was being allegedly flat in the middle.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 12826234
• MDR Text Key: 281006261
• Report Number: 1419652-2021-00042
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784238
• UDI-Public: (01)05055982784238(11)170427
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2021
• Distributor Facility Aware Date: 11/03/2021
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention